Health groups call on FDA to act on composite regulations after GLP-1 drug shortage

Health groups call on FDA to act on composite regulations after GLP-1 drug shortage

Today, the Obesity Action Coalition (OAC) and the Obesity Society (TOS) sent a letter to the US Food & Drug Administration (FDA), along with more than 20 leading organizations and providers across the healthcare continuum, to call on the agency to enforce federal regulations following the recent GLP-1 drug shortage resolution. Signatories include: The Alliance for Women's Health & Prevention, the Association of Black Cardiologists, the National Hispanic Medical Association and the National Consumers League.

The letter follows recent FDA announcements that Eli Lilly's tirzepatide, marketed as zepund for weight loss, and Novo Nordisk's semaglutide, marketed as Ozempic for diabetes and weight loss, are no longer defective. Additionally, a federal court in Texas recently rejected a preliminary injunction blocking the FDA's tirzepatide decision - underscoring Converter's "cessation" of all copycats.

Following the recent resolution of GLP-1 shortages, we welcome last week's FDA notice for GLP-1 compounds indicating that outsourcing facilities creating versions of Tirzepatide have until March 19 to commence operations. Pharmacies must stop supplying semaglutide by April 22, while larger outsourcing facilities have until May 22, or until the district court file for a pending injunction in the district court case - whichever comes first will take precedence.

The letter also acknowledges that U.S. regulations allow some compounding pharmacies to produce versions of brand-name drugs in limited circumstances, including shortages or as needed to meet the individual needs of a particular patient. However, the continued mass production compound of GLP-1s undermines the regulatory framework to protect patients from potential risks associated with unapproved and unregulated drug formulations.

To address this issue, the signatories call on the FDA to take the following actions:

1. Enforce Existing Regulations: Ensure compounding pharmacies comply with federal regulations by ceasing production of GLP-1 drugs after the deficiency is resolved.

2. Adherence Monitoring: Enforce adherence monitoring and enforcement measures during and after grace to prevent the unauthorized compounding of these medications.

3. Educate stakeholders: Provide clear guidance to healthcare providers, pharmacists, and patients about the transition to FDA-approved medications and the importance of obtaining treatments through appropriate channels.

4. Enforce Existing Rules Against Misleading Information: Ensure that companies that promote misleading information about GLP-1 compounded currents are held accountable under FDA's existing regulatory authority.

GLP-1 drugs are having a transformative impact on the obesity space. As these medications become increasingly popular, regulatory action and enforcement are critically needed at the state and federal levels to ensure that patients have access to safe, FDA-approved treatments. “

Joseph Nadglowski, president and CEO of the Obesity Action Coalition

“With the GLP-1 deficiency resolved, the FDA faces a critical juncture in maintaining its commitment to patient safety,” said Anthony Comuzzie, PhD, FTOS, CEO of TOS. “Our message is simple – FDA, it is time to take decisive action now by enforcing the existing regulatory framework for compounding.”

The letter was signed by the following organizations and doctors:

• Target alliance

• Alliance for Women's Health and Prevention

• Association of Black Cardiologists

• Bone Health & Osteoporosis Foundation

• Chronic Care Policy Alliance

• Color of gastrointestinal diseases

• Diabetes Patient Advocacy Coalition

• Global Liver Institute

• Healthy Women

• Repaired hearts

• Minority Health Institute

• National Alliance for Nursing

• National Black Nurses Association

• National Consumers League

• National Hispanic Health Foundation

• National Hispanic Medical Association

• Obesity Action Coalition

• The Obesity Society

• Womenheart

• Lyn Behnke, DNP, MSN

• Lisa Larkin, Md

• Spence Nadolsky, MD

I have taken tirzepatide for a year without any problems. There is no reason not to take a strengthened version. I think the Big Pharms are behind these groups and are paying them to publish these recommendations. This way we pay the higher prices of big pharma. It's in the best interest of Big Pharma.

These groups would rather have their patients die waiting for access to affordable medicines than risk the wrath of Eli Lilly? Don’t let the names of these “health groups” fool you. They do not look out for the best interests of their members.

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